Clinical Research Associate 2

This is a fully remote position, open to applicants in Australia.

📋 Description

• Facilitate the identification and selection of investigators and sites, including feasibility assessments.

• Execute monitoring activities in accordance with the established Monitoring Plan.

• Accurately prepare monitoring visit reports within specified deadlines.

• Organize, conduct, and report on evaluations of sites.

• Compile and submit regulatory documentation while managing import/export requirements and updates to the Ethics Committee package.

• Negotiate site budgets and oversee the execution of site contracts.

• Monitor invoicing and ensure timely payments to sites.

• Conduct initiation visits at trial sites.

• Create and sustain monitoring tools and documents specific to the project.

• Inspire and educate investigators and trial site personnel on protocols, investigational products, and trial standards.

• Gather, review, approve, and categorize essential trial-site documents for inclusion in the Trial Master File.

• Reconcile the contents of the in-house Trial Master File and the Investigator Site File.

• Oversee the distribution, tracking, handling, and disposal of investigational products and trial supplies.

• Maintain trial information using the clinical trial management system and related tracking/reporting tools.

• Assist in recruitment strategies.

⛳️ Requirements

• Relevant tertiary qualifications in a science or healthcare discipline.

• A minimum of 2 years’ experience in on-site monitoring and site management in an academic, CRO, or pharmaceutical setting is essential.

• Experience in renal and/or oncology clinical trials is an advantage.

• Practical understanding of ICH-GCP guidelines and both global and local ethical and regulatory research requirements.

• Proficiency in ethical considerations, participant safety, site start-up and conduct management, risk management, quality assurance, supply management, scientific concepts, clinical research design, and issue escalation.

• Skills in negotiation, conflict resolution, critical thinking, problem-solving, decision-making, and strategic thinking.

• Strong interpersonal communication and presentation abilities.

• Flexibility to work autonomously within a multidisciplinary team and engage with various stakeholders.

• Capacity to adapt to shifting organizational priorities and uncertain environments.

• Willingness and ability to travel as required.

🏝️ Benefits

• Competitive compensation with a customized salary and benefits package that reflects skills and experience.

• Options for hybrid or remote working arrangements, based on location and role.

• Opportunities for learning and access to a global network of scientific leaders.

• Employee wellbeing programs and initiatives that promote work-life balance, health, and team cohesion.

• Participation in global engagement surveys.

• Recognition programs.

• Team-building events.

• Exposure to a variety of international projects and clients.